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SMOFlipid® Bag

Logo: SMOFlipid

Approved for pediatric patients!

SMOFlipid is the only parenteral nutrition (PN) innovation with a unique blend of 4 oils in the US to nourish even the smallest patients.1

  • 30% Soybean oil
    Provides essential fatty acids.

  • 30% Medium-chain triglycerides (MCT)
    A source of rapidly available energy.2

  • 25% Olive oil
    Supplies monounsaturated fatty acids.

  • 15% Fish oil 
    A good source of omega-3 fatty acids, which include EPA and DHA.3

Important safety information>

Full prescribing information>

The same product you’ve trusted for adults is approved for children 17 and under who require PN

SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for PN when oral or enteral nutrition is not possible, insufficient, or contraindicated.1

SMOFlipid helps to nurture growth in pediatric patients1,4-6

  • Infants receiving SMOFlipid experienced adequate growth.*1
  • Preterm infants receiving SMOFlipid experienced higher EPA and DHA levels compared to those receiving a soybean oil lipid emulsion.† 4,5
  • SMOFlipid is associated with a lower omega-6 to omega-3 polyunsaturated fatty acid ratio compared to soybean oil–based lipid emulsions in preterm neonates.5,6
  • SMOFlipid has a well-established safety and tolerability profile.1

*One company-sponsored trial showed equivalent total bilirubin and direct bilirubin levels comparing SMOFlipid with a soybean-based ILE.

†Based on composition of the product.

EPA and DHA (omega-3 fatty acids) are considered to be important for healthy development of infants due to their physiological roles7,8

  • May be considered conditionally essential for growth and development9,10

  • Important structural elements of cell membranes8

Appropriate dosing is vital

The dosing of SMOFlipid varies in pediatrics, neonates, and adults; each group has its own unique dosing specifications.1

Age Nutritional Requirements Direct Infusion Rate
Recommended Initial Dosage and Maximum Dosage Initial Maximum
Birth to 2 years of age (including preterm and term neonates*) Initial 0.5 to 1 g/kg/day
not to exceed 3 g/kg/day**		 0.1 to 0.2 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes 0.75 mL/kg/hour
Pediatric patients 2 to <12 years of age Initial 1 to 2 g/kg/day
not to exceed 3 g/kg/day**		 0.2 to 0.4 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes 0.75 mL/kg/hour
Pediatric patients 12 to 17 years of age Initial 1 g/kg/day
not to exceed 2.5 g/kg/day**		 0.2 to 0.4 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes 0.75 mL/kg/hour
Adults 1 to 2 g/kg/day
not to exceed 2.5 g/kg/day**		 0.2 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes 0.5 mL/kg/hour

*The neonatal period is defined as including term, post-term, and preterm newborn infants. The neonatal period for term and post-term infants is the day of birth plus 27 days. For preterm infants, the neonatal period is defined as the day of birth through the expected age of delivery plus 27 days (i.e., 44 weeks post-menstrual age).

**Daily dosage should not exceed a maximum of 60% of total energy requirements.

  • Protect the admixed PN solution from light
  • Use a non-vented, non-DEHP 1.2 micron in-line filter set during administration

SMOFlipid has a well-established safety and tolerability profile.1 It has been administered to more than 7 million patients worldwide.*

*Data on file 12/1/23.

Order

ORDERING INFORMATION
NDC Code 63323-820-00 63323-820-74 63323-820-50 63323-820-10
Bag Size 100 mL 250 mL 500 mL 1000 mL
Bags/Case 10 bags/box 10 bags/box 12 bags/box 6 bags/box

KabiCare Patient Support Program for Parenteral Nutrition

Fresenius Kabi’s patient support program, KabiCare, offers online resources for claims appeals and billing as well as coding guides for parenteral nutrition.

Learn more

SMOFlipid resources

Explore additional SMOFlipid materials by visiting our Resource Center.

Download Stability Reference Guide for Pediatrics>

Download Compatibility Tool*>


Learn more
Expand for Important Safety Information

The most common side effects (>1%) in adult patients include nausea, vomiting, and high levels of glucose in the blood and in pediatric patients include low levels of red blood cells, vomiting, increased levels of liver enzymes (i.e., gamma-glutamyltransferase) and hospital-acquired infections.

These are not all the possible side effects associated with SMOFlipid. Call your healthcare provider for medical advice regarding SMOFlipid side effects. You are encouraged to report negative side effects of SMOFlipid. Contact Fresenius Kabi USA, LLC at: 1-800-551-7176 or FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch. The FDA-approved product labeling can be found at https://www.FreseniusKabiNutrition.com/SMOFlipidPI.

For Healthcare Professionals

SMOFLIPID (lipid injectable emulsion, USP), for intravenous use

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.

IMPORTANT SAFETY INFORMATION

For intravenous infusion only into a central or peripheral vein. Use a non-vented non-DEHP 1.2 micron in-line filter set during administration. Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize and eliminate lipids, and consideration of additional energy given to the patient. The recommended dose for adults and pediatrics is shown in Table 1. For information on age-appropriate infusion rate, see the full prescribing information. SMOFlipid Pharmacy Bulk Package is only indicated for use in pharmacy admixture programs for the preparation of three-in-one or total nutrition admixtures. Protect the admixed PN solution from light.

Table 1: Recommended Adult and Pediatric Dosage

Age Nutritional Requirements
Initial Recommended Dosage Maximum Dosage
Birth to 2 years of age (including preterm and term
neonates)		 0.5 to 1 g/kg/day 3 g/kg/day
Pediatric patients 2 to <12 years of age 1 to 2 g/kg/day 3 g/kg/day
Pediatric patients 12 to 17 years of age 1 g/kg/day 2.5 g/kg/day
Adults 1 to 2 g/kg/day 2.5 g/kg/day

SMOFlipid is contraindicated in patients with known hypersensitivity to fish, egg, soybean, peanut, or any of the active or inactive ingredients, and severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL).

Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported.

Parenteral Nutrition-Associated Liver Disease: Increased risk in patients who received parenteral nutrition for greater than 2 weeks, especially preterm neonates. Monitor liver tests; if abnormalities occur consider discontinuation or dosage reduction.

Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reactions occur.

Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, Hypertriglyceridemia, and Essential Fatty Acid Deficiency: Monitor for signs and symptoms; monitor laboratory parameters.

Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm neonates.

Most common adverse drug reactions (≥5%) from clinical trials in adults were nausea, vomiting, and hyperglycemia. Most common adverse drug reactions (≥5%) from clinical trials in pediatric patients were anemia, vomiting, increased gamma-glutamyltransferase, and nosocomial infection.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This Important Safety Information does not include all the information needed to use SMOFlipid safely and effectively. Please see full prescribing information for SMOFlipid (lipid injectable emulsion, USP), for intravenous use at www.FreseniusKabiNutrition.com/SMOFlipidPI.

Expand

The most common side effects (>1%) in adult patients include nausea, vomiting, and high levels of glucose in the blood and in pediatric patients include low levels of red blood cells, vomiting, increased levels of liver enzymes (i.e., gamma-glutamyltransferase) and hospital-acquired infections.

These are not all the possible side effects associated with SMOFlipid. Call your healthcare provider for medical advice regarding SMOFlipid side effects. You are encouraged to report negative side effects of SMOFlipid. Contact Fresenius Kabi USA, LLC at: 1-800-551-7176 or FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch. The FDA-approved product labeling can be found at https://www.FreseniusKabiNutrition.com/SMOFlipidPI.

For Healthcare Professionals

SMOFLIPID (lipid injectable emulsion, USP), for intravenous use

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.

IMPORTANT SAFETY INFORMATION

For intravenous infusion only into a central or peripheral vein. Use a non-vented non-DEHP 1.2 micron in-line filter set during administration. Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize and eliminate lipids, and consideration of additional energy given to the patient. The recommended dose for adults and pediatrics is shown in Table 1. For information on age-appropriate infusion rate, see the full prescribing information. SMOFlipid Pharmacy Bulk Package is only indicated for use in pharmacy admixture programs for the preparation of three-in-one or total nutrition admixtures. Protect the admixed PN solution from light.

Table 1: Recommended Adult and Pediatric Dosage

Age Nutritional Requirements
Initial Recommended Dosage Maximum Dosage
Birth to 2 years of age (including preterm and term
neonates)		 0.5 to 1 g/kg/day 3 g/kg/day
Pediatric patients 2 to <12 years of age 1 to 2 g/kg/day 3 g/kg/day
Pediatric patients 12 to 17 years of age 1 g/kg/day 2.5 g/kg/day
Adults 1 to 2 g/kg/day 2.5 g/kg/day

SMOFlipid is contraindicated in patients with known hypersensitivity to fish, egg, soybean, peanut, or any of the active or inactive ingredients, and severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL).

Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported.

Parenteral Nutrition-Associated Liver Disease: Increased risk in patients who received parenteral nutrition for greater than 2 weeks, especially preterm neonates. Monitor liver tests; if abnormalities occur consider discontinuation or dosage reduction.

Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reactions occur.

Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, Hypertriglyceridemia, and Essential Fatty Acid Deficiency: Monitor for signs and symptoms; monitor laboratory parameters.

Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm neonates.

Most common adverse drug reactions (≥5%) from clinical trials in adults were nausea, vomiting, and hyperglycemia. Most common adverse drug reactions (≥5%) from clinical trials in pediatric patients were anemia, vomiting, increased gamma-glutamyltransferase, and nosocomial infection.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This Important Safety Information does not include all the information needed to use SMOFlipid safely and effectively. Please see full prescribing information for SMOFlipid (lipid injectable emulsion, USP), for intravenous use at www.FreseniusKabiNutrition.com/SMOFlipidPI.

If you still can't find what you're looking for regarding our PN products or Fresenius Kabi Nutrition, let us know and we can help.

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References: 1. SMOFlipid Prescribing Information, Fresenius Kabi USA, LLC. 2023. 2. Deckelbaum RJ, Hamilton JA, Moser A, et al. Medium-chain versus long-chain triacylglycerol emulsion hydrolysis by lipoprotein lipase and hepatic lipase: implications for the mechanisms of lipase action. Biochemistry. 1990;29(5):1136-1142. 3. Kalish BT, Fallon EM, Puder M. A tutorial on fatty acid biology. JPEN J Parenter Enteral Nutr. 2012;36(4):380-388. 4. Vlaardingerbroek H, Vermeulen MJ, Carnielli VP, et al. Growth and fatty acid profiles of VLBW infants receiving a multicomponent lipid emulsion from birth. J Pediatr Gastroenterol Nutr. 2014;58(4):417-427. 5. Rayyan M, Devlieger H, Jochum F, Allegaert K. Short-term use of parenteral nutrition with a lipid emulsion containing a mixture of soybean oil, olive oil, medium-chain triglycerides, and fish oil: a randomized double-blind study in preterm infants. JPEN J Parenter Enteral Nutr. 2012;36(1 Suppl):81S-94S. 6. Ariyawangso U, Puttilerpong C, Ratanachu-ek S, Anuntkosol M. Short-term safety and efficacy of fish-oil emulsions on the prevention of parenteral nutrition-associated liver disease in surgical neonates: a randomized controlled trial. Thai J Pharmac Sci. 2014;38(4):156-209. 7. Agostoni C. Role of long-chain polyunsaturated fatty acids in the first year of life. J Pediatr Gastroenterol Nutr. 2008;47 Suppl 2:S41-44. 8. Cetin I, Koletzko B. Long-chain omega-3 fatty acid supply in pregnancy and lactation. Curr Opin Clin Nutr Metab Care. 2008;11(3):297-302. 9. Lapillonne A, Groh-Wargo S, Gonzalez CH, Uauy R. Lipid needs of preterm infants: updated recommendations. J Pediatr. 2013;162(3 Suppl):S37-47. 10. Bistrian BR. Clinical aspects of essential fatty acid metabolism: Jonathan Rhoads Lecture. JPEN J Parenter Enteral Nutr. 2003;27(3):168-175.

* For additional information about the testing results, and for more insights into how to use this information for your PN patients, please contact Fresenius Kabi Medical Affairs via phone at 1-800-551-7176, option 4, or email Nutrition.MedInfo.USA@fresenius-kabi.com.